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Alkylating Agent

Veliparib + Temozolomide for Leukemia

Phase 1

Waitlist Available

Led By Ivana Gojo

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed or refractory pre-B- or T-cell acute lymphoblastic leukemia (ALL); patients with Philadelphia chromosome-positive (Ph+) ALL [t(9;22)] will be eligible provided that they have failed (intolerance/resistance) at least 2 different tyrosine kinase inhibitors (TKIs) or have a mutation associated with resistance to TKIs (T315I)

Chronic myelogenous leukemia (CML) in accelerated or blastic phase; patients failed (resistance/intolerance) at least 2 different TKIs or have a mutation associated with resistance to TKIs (T315I)

Must not have

Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or temozolomide used in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 6 hours after drug administration on day 1 of course 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of giving veliparib with temozolomide to treat leukemia. Veliparib may stop cancer cell growth by blocking enzymes needed for cell growth. Temozolomide may kill or stop cancer cells from dividing. Giving veliparib with temozolomide may kill more cancer cells.

Who is the study for?

This trial is for adults with various types of acute leukemia, including those who have relapsed or are not responding to other treatments. It's also open to older patients who can't undergo intensive chemotherapy and those with certain genetic mutations. Participants must be able to swallow pills, have no severe infections or illnesses that could interfere with the study, and agree to use contraception.

What is being tested?

The trial is testing the combination of two drugs: Veliparib and Temozolomide. The goal is to find the safest dose that effectively treats acute leukemia by blocking enzymes cancer cells need for growth while stopping their division. This phase I trial will also look at how these drugs affect biomarkers in lab tests.

What are the potential side effects?

Potential side effects from Veliparib and Temozolomide may include allergic reactions similar to other compounds in their class, issues related to uncontrolled infections if present, heart problems like congestive heart failure or arrhythmias, psychiatric conditions affecting compliance, as well as risks associated with pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia has returned or didn't respond to treatment, and I've tried at least 2 TKIs without success.

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My CML is in an advanced stage and I've not responded to at least 2 TKIs or have a specific resistance mutation.

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I had a stem cell transplant over 60 days ago, have no graft vs. host disease, and stopped all immunosuppressive therapy over 2 weeks ago.

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I finished chemotherapy 3 weeks ago and radiotherapy 2 weeks ago, with no severe side effects.

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My AML has returned or didn't respond to treatment, including failure with tretinoin, arsenic, and gemtuzumab.

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I cannot undergo or have already tried all known curative treatments.

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I am 60 or older with AML and cannot undergo strong chemotherapy due to high-risk factors.

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My leukemia is caused by previous cancer treatments.

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My AML developed from a previous blood disorder.

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My leukemia is classified as CMML-2 based on my blood and bone marrow tests.

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I can take care of myself but might not be able to do heavy physical work.

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I am a woman who can have children and I have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses that would stop me from following the study's requirements.

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I am allergic to medications similar to ABT-888 or temozolomide.

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I am not pregnant and will stop breastfeeding to receive treatment.

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I am not currently on any experimental treatments or receiving chemotherapy, radiation, or immunotherapy.

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I have been treated with temozolomide before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 6 hours after drug administration on day 1 of course 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 6 hours after drug administration on day 1 of course 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 hours after drug administration on day 1 of course 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Average change from baseline level in RAD51 foci

Average change from baseline level in y-H2AX foci

Average expression of MGMT

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (temozolomide and veliparib)Experimental Treatment4 Interventions

Patients receive veliparib PO QD on day 1 and twice daily on days 4-12 and temozolomide PO QD on days 3-9 of course 1. Beginning at least 30 days after the start of treatment, patients receive veliparib PO BID on days 1-8 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission receive 5 more courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Veliparib

2012

Completed Phase 3

~4780